Data / Medical devices / United States / Ototronix, LLC (Minnesota)
Ototronix, LLC (Minnesota): FDA-registered device maker in White Bear Township, MN, United States, 1 510(k) clearance and 1 PMA approval
Ototronix, LLC (Minnesota) is registered with the FDA (registration 3012118649) in White Bear Township, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated June 19, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012118649
- Address
- 5000 Township Pkwy, White Bear Township, MN, United States, 55110
- Owner or operator
- Ototronix, LLC (10031730)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- March 3, 2010
- Registered through
- 2026
- Brand names listed
- Maxum, ProCem
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Ear, Nose And Throat | NEA | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Hearing, Active, Middle Ear, Partially Implanted | MPV | 3 | Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 19, 2014 | K140644 | PROCEM | NEA | Substantially Equivalent | Ototronix, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 7, 2001 | P010023 | SOUNDTEC DIRECT SYSTEM | MPV | 14 | October 28, 2020 | accessdata.fda.gov |
Compare with other makers
Updated October 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.